NCT06639880

Brief Summary

This study was conducted on forty male patients (15 in the control group and 25 in the study group)) with low back pain hyperkyphosis of the thoracic spine, ages ranged from 20 - 40 years old. The visual analogue scale, the Oswestry disability questionnaire, and Cobb's angle was assessed for all patients before any intervention and two months post-intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable low-back-pain

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2023

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 2, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 2, 2024

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 15, 2024

Completed
Last Updated

October 15, 2024

Status Verified

October 1, 2024

Enrollment Period

1 year

First QC Date

October 8, 2024

Last Update Submit

October 10, 2024

Conditions

Low Back Pain

Keywords

hyperkyphosisCobb's angle

Outcome Measures

Primary Outcomes (2)

  • level of percieved pain

    The visual analogue scale used to evaluate level of percieved pain

    six weeks

  • thoracic kyphosis angle

    x-ray cobb's angle used to evaluate the degree of hyper kyphosis of the lumbar spine

    six weeks

Secondary Outcomes (1)

  • degree of disability

    six weeks

Study Arms (2)

study group

EXPERIMENTAL

triple attack protocol which includes a modified P-A mobilization, manipulation, and stabilization program (Active and passive) for the thoracic spine in addition to the usual care and the core program for the lumbar spine

Other: triple attack protocol

control

ACTIVE COMPARATOR

the usual care for the lumbar spine which includes TENS, ultrasound, and myofascial release for the lumbar spine in addition to a core program including bridge, half bridge and clam shell exercise

Other: usual care exercise

Interventions

usual care exerciseOTHER

the usual care for the lumbar spine which includes TENS, ultrasound, and myofascial release for the lumbar spine in addition to a core program including bridge, half bridge and clam shell exercise

control
triple attack protocolOTHER

a modified P-A mobilization, manipulation, and stabilization program (Active and passive) for the thoracic spine in addition to the usual care and the core program for the lumbar spine

study group

Eligibility Criteria

Age20 Years - 40 Years
Sexmale
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • patients who has low back pain due to facet joint arthropathy or discogenic cause confirmrd by MRI. Chronic spine instability confirmed by clinical tests. Sacroiliac joint confirmed by claster of lattelets. Hyperkyphosis (\>40 degree measured by cobb's angle)

You may not qualify if:

  • any structural deformity (wedge fracture) or previous spinal surgeries. Spinal tumors or fracture or presence of active infection in the lumbar spine. Systematic disorder (Rheumatoid) Cauda equine lesion, the presence of any comorbidities such as hypertension, DM, hyperlipidemia, obesity, and any autoimmune disease, history of patients who suffered from cancer, unexplained weight loss, immunosuppression, prolonged use of steroids, intravenous drug use, urinary tract infection, pain that is increased or unrelieved by rest, fever, significant trauma related to age, bladder or bowel incontinence, urinary retention (with overflow incontinence), saddle anesthesia, loss of anal sphincter tone, major motor weakness in lower extremities, fever, and vertebral tenderness.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Faculty of Physical Therapy

Giza, 12556, Egypt

Location

Faculty of physical Therapy Cairo University

Giza, 12613, Egypt

Location

MeSH Terms

Conditions

Low Back PainKyphosis

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal CurvaturesSpinal DiseasesBone DiseasesMusculoskeletal Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
lecturer of Biomechanics

Study Record Dates

First Submitted

October 8, 2024

First Posted

October 15, 2024

Study Start

January 1, 2023

Primary Completion

January 2, 2024

Study Completion

January 2, 2024

Last Updated

October 15, 2024

Record last verified: 2024-10

Locations

EG(2)